MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE® LI-ION BATTERY

Model Number 8700-0752-01

Device Problems Premature Discharge of Battery (1057); Device Inoperable (1663); Battery Problem (2885)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 07/03/2014

Event Type  malfunction  

Event Description

The initial call was for a (b)(6) female patient weighing (b)(6) pounds in cardiac arrest on (b)(6) 2014 at 06:21 hours.The incident occurred at the patient's residence and was unwitnessed.The patient was down for an unknown length of time.Bystander cpr was performed by the sheriff's deputy.Length of time was not provided.There were 3 ems and 2 sheriffs on scene.Manual cpr was performed by the responding agency for 14 minutes prior to use of the autopulse.The autopulse was deployed without any issues.A "new" fully charged li-ion battery was exhausted after only 5 minutes of use.The autopulse was restarted, however, it stopped performing after just one compression.Medics did not have a spare battery on scene.No messages were observed on the lcd display after the reported issue was observed.Use of the autopulse was discontinued and manual cpr was continued for 8 minutes.Total length of time that cpr was performed including manual and automated was 27 minutes.The patient was slid onto the long spine backboard in the bathroom and moved into the hallway.However, the patient was not transported to the hospital.The patient was pronounced dead after consultation with the on-line physician.There were no signs or symptoms of trauma.Return of spontaneous circulation (rosc) was never achieved.The cause of the cardiac arrest is unknown.The cause of death is unknown.It is unknown if the autopsy report is complete or available.Patient had a history of diabetes and cardiac stents.Customer (assistant fire chief) did not attribute the patient's death to the autopulse stoppage.No further information was provided.

Manufacturer Narrative

Please see the following related mfr report: # 3003793491-2014-00383 for autopulse platform s/n (b)(4).Customer also reported that the daily check of the autopulse consisted of switching out the current battery, turning on the autopulse and once it started up, it was powered off and ready for use.Zoll has not yet received the autopulse battery in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

Please note that the following sections have been updated: serial number; device available for evaluation.The li-ion battery (s/n (b)(4)) was returned to manufacturer for analysis.Visual inspection of the returned battery shows that the locking latch was broken.The physical damage found during visual inspection is not related to the reported event.The li-ion battery s/n (b)(4) used at the time of the event was returned with the platform.An investigation conducted using the battery serial number, found that the battery was within its expected life span of 2-4 years.The autopulse system labeling requires the user to "test cycle" each battery monthly.Given that this battery only showed 5 test cycles and should have had 9±1, it can be concluded that the customer was not performing proper battery management.Although the autopulse archive indicated that the li-ion battery s/n (b)(4) ran for a very short time during the event, the battery archive data did not reveal any issues.The battery was fully charged and functionally evaluated with the autopulse platform for 30 minutes without any issues.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 3976672
• MDR Text Key: 4823305
• Report Number: 3003793491-2014-00384
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0752-01
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MANUAL CPR
• Patient Age: 54 YR
• Patient Weight: 91